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Axonics Modulation Technologies, Inc. recalls BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,
Recalled July 21, 2021 · FDA recall Z-2077-2021 · Axonics Modulation Technologies
Hazard
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized · FDA Class II
Units
2,702 units
Sold at
US nationwide distribution.
Description
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Product
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Manufacturer(s)
Axonics Modulation Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →